Evaluation of the Safety and Effectiveness of the DuraHeart™ LVAS
NCT ID: NCT00710567
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
66 participants
INTERVENTIONAL
2008-07-31
2018-11-12
Brief Summary
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Study Population The patient population for this trial consists of patients with end stage heart failure awaiting cardiac transplantation. Patients must be listed for transplant with UNOS with status 1A or 1B. All patients who meet the eligibility criteria may be included in the study regardless of gender, race or ethnicity.
Study Design This is a multi-center, prospective, single arm study in which the lower one-sided confidence interval exceeds the performance goal. Enrollment is expected to occur within an 18-month time period at up to 40 centers. All patients will be followed for all endpoints for 6 months while on DuraHeart™ LVAS support, or until cardiac transplantation or death, whichever occurs first. For those patients who remain on support after 180 days, survival and device reliability data will continue to be collected on a regular basis. If patients are transplanted, survival at day 30 post cardiac transplantation will also be assessed.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Historical Data
DuraHeart Patients will be implanted with a DuraHeart Left Ventricular Assist System (LVAS) as a "bridge to transplant" until a suitable heart can be found as a replacement. Parameters collected will be compared to a performance goal based on historical data for congestive heart failure patients
DuraHeart Left Ventricular Assist System (LVAS)
The DuraHeart LVAS is implanted in using open heart surgery
Interventions
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DuraHeart Left Ventricular Assist System (LVAS)
The DuraHeart LVAS is implanted in using open heart surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
1. Approved for cardiac transplantation
2. Listed with UNOS on the Status 1 list
3. Patient for whom LVAS implantation is planned as a clinically indicated bridge to cardiac transplantation
Exclusion Criteria
1. Contraindication to the administration of warfarin or anti-platelet agents
2. Primary coagulopathy or platelet disorder
3. Acute myocardial infarction within 48 hours prior to enrollment
4. Anticipated need for RVAD support or ECMO at the time of LVAS implantation
5. Prior cardiac transplantation, left ventricular reduction surgery, cardiomyoplasty, passive restraint device (i.e., CorCapTM Cardiac Support Device) or surgically implanted left ventricular assist device
18 Years
ALL
No
Sponsors
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Terumo Heart Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Francis D. Pagani, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Yoshifumi Naka, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Columbia University
David S Feldman, MD
Role: PRINCIPAL_INVESTIGATOR
Minneapolis Heart Institute
Locations
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University of Alabama
Birmingham, Alabama, United States
Mayo Clinic - Phoenix
Phoenix, Arizona, United States
University of Arizona Medical Center
Tucson, Arizona, United States
University of Southern California
Los Angeles, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
St. Joseph's Hospital of Atlanta
Atlanta, Georgia, United States
St. Vincent Hospital
Indianapolis, Indiana, United States
University of Michigan
Ann Arbor, Michigan, United States
Minneapoils Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Newark Beth Israel
Newark, New Jersey, United States
Mt. Sinai School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
Penn State University
Hershey, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Medical City
Dallas, Texas, United States
Methodist Hospital
Houston, Texas, United States
Texas Heart Institute
Houston, Texas, United States
Sacred Heart Medical Center
Spokane, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Toronto General Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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DH003
Identifier Type: -
Identifier Source: org_study_id